Comparison between intra-articular ozone and placebo in the treatment of knee osteoarthritis: A randomized, double-blinded, placebo-controlled study.

Carlos César Lopes De Jesus,Fânia Cristina Dos Santos,Luciana Maria Oliveira Bueno De Jesus,Virginia Fernandes Moça Trevisani,Maria Sonia Sousa Castro Sant’Ana,Iara Monteiro,Jan P A Baak

doi:10.1371/journal.pone.0179185

Carlos César Lopes De Jesus, Fânia Cristina Dos Santos + Show 5 more

Open Access

https://doi.org/10.1371/journal.pone.0179185

Copy DOI

Abstract

ObjectiveThe aim of the trial was to determine the effectiveness of oxygen-ozone injections on knee osteoarthritis concerning pain reduction, joint functional improvement, and quality of life.MethodsIn this randomized, double-blinded, placebo controlled clinical trial, 98 patients with symptomatic knee osteoarthritis (OA) were randomized into two groups receiving intra-articular 20 μg/ml of ozone (OZ) or placebo (PBO) for 8 weeks. The efficacy outcomes for knee OA were the Visual Analogue Scale (VAS), Lequesne Index, Timed Up and Go Test (TUG Test), SF-36, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and Geriatric Pain Measure (GPM).ResultsAfter 8 weeks of treatment, ozone was more effective than the placebo: VAS [mean difference (MD) = 2.16, p < 0.003 (CI 95% 0.42–3.89)], GPM [MD = 18.94, p < 0.004 (CI 95% 3.43–34.44)], LEQ [MD = 4.05, p < 0.001 (CI 95% 1.10–7.00)], WOMAC (P) [median of diff = 9.999, p = 0.019 (CI 95% 0.000–15.000)], WOMAC (JS) [median of diff = 12.499, p < 0.001 (CI 95% 0.000–12.500)], WOMAC (PF) = [median of diff = 11.760, p = 0.003 (CI 95% 4.409–19.119)], TUG (no statistical difference) and SF-36 (FC) [(MD = -25.82, p < 0.001 (CI 95% 33.65–17.99)], SF-36 (PH) [MD = -40.82, p < 0.001 (CI 95% -54.48–27.17)], SF-36 (GSH) [MD = -3.38, p < 0.001 (CI 95% -4.83–1.93)], SF-36 (SA) [MD = 2.17, p < 0.001 (CI 95% -19.67–8.24), SF-36 (EA) [MD = -35.37, p < 0.001 (CI 95% -48.86–21.89)]. Adverse events occurred in 3 patients (2 in the placebo group and 1 in the ozone group) and included only puncture accidents.ConclusionsThe study confirms the efficacy of ozone concerning pain relief, functional improvement, and quality of life in patients with knee osteoarthritis.Trial registrationInternational Standard Randomized Controlled Trial Number Register ISRCTNR55861167

Highlights

Osteoarthritis (OA) is a group of common, age-related clinical conditions affecting synovial joints [1]
The study confirms the efficacy of ozone concerning pain relief, functional improvement, and quality of life in patients with knee osteoarthritis
The diagnosis of osteoarthritis is based on the history and physical conditions, radiographic findings, including asymmetric joint space narrowing, subchondral sclerosis, osteophyte formation, subluxation and distribution patterns of osteoarthritic alterations can be helpful when the diagnosis is in question [6, 7]

Summary

Introduction

Osteoarthritis (OA) is a group of common, age-related clinical conditions affecting synovial joints [1]. There are few articles on the use of intra-articular ozone in the treatment of knee osteoarthritis and those that exist are clinical series reports [10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20]. It is interesting to note that in these clinical series, ozone treatment for knee osteoarthritis resulted in a marked clinical improvement in pain and function. Taking into account these results, a double-blinded, PBO controlled clinical trial was designed to assess the efficacy of O3 in patients with symptomatic knee OA concerning pain reduction and functional improvement

Objectives

Methods

Results